MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION CAROTID GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the involved destination was used during the procedure.When power injecting through the sheath with a.035 glidewire advantage in the sheath and without the wire, contrast sprayed from the valve on both instances.No blood leaked otherwise.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.The procedure was completed.Additional information was received on 22oct2020.The procedure performed was a right leg angiogram up and over.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6 fr 90 cm destination device along with the dilator mated was received for product evaluation at.Visual inspection revealed no damage on the sheath or dilator assemblies.Functional testing was performed, the sheath hub was connected to the luer collar of the sheath and was flushed to observe if any leakage was present.No leakage was observed through the valve.Ifu states: "do not use power injector through the side tube and three way stopcock.The complaint cannot be confirmed for fluid issues since the device performed without any issue.Based on the available information, although the exact cause of the event cannot be determined, the use of a power injector violating the ifu likely led to the damage.The leakage may also have occurred if the luer collar was not securely tightened to the sheath hub.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: DESTINATION CAROTID GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10835092
• Report Number: 1118880-2020-00285
• Device Sequence Number: 14402713
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: 00389701007847
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSC05
• Device Lot Number: 0000001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUQA VERT CATHETER; GLIDEWIRE ADVANTAGE; AUQA VERT CATHETER; GLIDEWIRE ADVANTAGE
• Patient Age: 81 YR
• Patient Weight: 93